Delivery of stents or covered stents to the vasculature is often provided via percutaneous delivery that involves the Seldinger approach. Following access to the vasculature via a needle, a guidewire is entered through the needle and the needle is removed. With the guidewire in place in the vessel, a dilator with an external introducer sheath is then advanced over the wire into the vessel. Upon removal of the dilator, the introducer sheath is left in place to provide an access channel for entry of an interventional catheter. This introducer sheath enlarges the vessel to a diameter that is larger than the interventional catheter, and makes the diameter of the access site larger than necessary in some cases. Closure of the access site can then present a problem for large diameter access sites that are intended for large diameter interventional catheters, particularly when the patient is being heparinized.
Transcatheter Aortic Valve Implantation (TAVI), Abdominal Aortic Aneurysm repair, and other minimally invasive procedures require that large introducer sheaths be placed percutaneously into the vasculature in order to provide passage for these devices intended to repair or replace the damaged vessel or body tissue. Often the catheters have profiles that range from 16 to 21 French or larger. Vascular closure of such large arteriotomy sites following the removal of the large introducer sheath can be very difficult and often can require surgical intervention. Most percutaneous closure device do not perform well to close such large arteriotomy sites where the diameter of the arteriotomy is almost as large as the diameter of the vessel. One closure device that utilizes an anchor material on the inside of the vessel attached to a plug material on the outside works well for smaller diameter access closure but is not reliable for larger diameter access site closure. Other percutaneous closure devices that utilize sutures also have difficulty ensuring that the large diameter arteriotomy site is consistently closed. Manual compression of the large diameter access site can require a long period of time and can be associated with continued blood oozing and the formation of a hematoma.
What is needed is a device that can easily and consistently close a large diameter access site. The device should allow closure of the access site within only a few seconds after removal of the large introducer that provided access to the large interventional catheter. Since the femoral access site often contains plaque deposit, the closure device should not be limited by such plaque. Also, since the femoral artery is generally the access site of preference, the device should not be prone to kinking or collapse due to external pressure that may be applied to the skin or due to bending that can occur at the femoral arterial access site. The profile of a vascular closure device should have a profile that allows its use without requiring excessive or complicated delivery.